Location: Mounds View, MN
Duration: 6+ months
Job Description
- Associate level Information Developer/Project Manager to assist with planning, researching, and writing requirements and content for Instructions for Use (IFUs) for products that treat diseases of the cardiovascular system.
- Deliverables include clinician reference manuals, product inserts, online help, etc.
- Users of this information may include regulators, clinicians, patients, and technical support representatives.
Typical Job Duties/Responsibilities
- Assist in planning, researching, and writing requirements and content for Instructions for Use (IFUs).
- Learn how regulations, standards, laws, process and content-related regulatory requirements, product specifications, and internal procedures drive the design of the IFUs.
- Support project teams as necessary, including implementing decisions about distribution and local language plans and regulatory requirements, researching rationale for historical content changes, routing documents for review in enterprise configuration management systems, assisting in writing product development process deliverables, etc.
- Participate in developing and maintaining project schedules and estimates.
- Communicate task status.
- Coordinate layout and design of deliverables with graphic designer and/or print specifications expert.
- Participate in content and quality reviews.
- Coordinate translations.
- Obtain access to and learn how to navigate within a variety of document control and configuration management systems, processes and tools.
- Apply creativity to solve problems related to processes, systems, and tools.
Minimum Qualifications
- Undergraduate Degree: Technical communications degree with project management emphasis, OR Other scientific or engineering degree with technical communications minor
- Acrobat Reader REQUIRED
- FrameMaker Front Page DESIRED
- Excellent Written Communication
- Demonstrated tools proficiency and aptitude
- Preference for having to interact with people in order to complete an assignment vs. working on your own
- Ability to write documentation that is clear, concise, consistent, and accurate
Preferred Qualifications
- Familiarity with ISO regulations, FDA QSR Design Controls, GMP, etc.
- Outstanding communication and interpersonal skills; ability to build strong relationships with peers
- Excellent problem-solving skills
- A solid understanding of user-experience principles
- Proficiency in writing in structured authoring environments